Evaluation of the National Tool for Observation of Infection Prevention Measures in the Healthcare (NOST)

Sponsor
Norwegian Institute of Public Health (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05721183
Collaborator
(none)
600
1
2
24
25

Study Details

Study Description

Brief Summary

The Norwegian Institute of Public Health (NIPH) is introducing a new electronic tool for direct observation of compliance with recommended infection prevention and control measures in healthcare. The solution is called the National Tool for Observation of Infection Prevention Measures (NOST). NOST is a quality improvement tool that includes a web-based solution for observing compliance with recommendations for hand hygiene and other IPC measures. Through NOST, healthcare personnel will be able to identify the local level of compliance, which in turn can reveal areas for improvement.

This protocol includes the evaluation of NOST in hospitals. The evaluation is designed as a cluster-randomized controlled trial with two arms where eligible wards in hospitals are randomly allocated into an intervention and a control arm. NOST is implemented in the intervention wards at the start of the evaluation period, and compliance with hand hygiene and other outcomes are measured in both the interventions and control wards one year later.

The objective of evaluating NOST is to:
  • measure if implementation of NOST leads to improved infection prevention and control in the form of increased compliance with hand hygiene recommendations, and

  • measure if changes in the quality of infection prevention and control as a result of implemented NOST affects the epidemiology of healthcare-associated infections in healthcare institutions and the length of hospital stays.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: NOST
N/A

Detailed Description

The evaluation og NOST is designed as a cluster-randomized controlled trial with two arms where eligible wards in hospitals are randomly allocated into an intervention and a control arm. NOST is implemented in the intervention wards at the start of the evaluation period, and compliance with hand hygiene and other outcomes are measured in both the interventions and control wards one year later.

Intervention

The intervention in the study is to implement NOST, which includes:
  • observation and recording of compliance with hand hygiene recommendations

  • identification of areas for improvement

  • training or other actions taken to improve IPC in general or compliance with hand hygiene.

Thus, the intervention includes both observation of compliance and any additional improvement measures initiated as a result of the introduced NOST.

Observations of hand hygiene will be carried out in sessions of 20-30 minutes. During this period, all situations where hand hygiene is indicated (recommended) and whether hand hygiene is performed or not, are recorded. The number of hand hygiene indications during a session varies but will often be between 10 and 20.

When the intervention group has implemented and followed NOST for a year, the investigators will measure compliance with hand hygiene recommendations and reported HAIs, in wards that have had NOST and in wards that have not introduced NOST.

The intervention arm will be followed over time with repeated measurements of both compliance with hand hygiene and other outcome measures, to see if the effect increases in line with implemented observations and quality improvement measures, or if the effect decreases during the study period.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The intervention is to implement NOST, which includes: observation and recording of compliance with hand hygiene recommendations identification of areas for improvement training or other actions taken to improve IPC in general or compliance with hand hygiene. Thus, the intervention includes both observation of compliance and any additional improvement measures initiated as a result of the introduced NOST. When the intervention group has implemented and followed NOST for a year, investigators will measure compliance with hand hygiene recommendations and reported HAIs, in wards that have had NOST and in wards that have not introduced NOST. The intervention arm will be followed over time with repeated measurements of both compliance with hand hygiene and other outcome measures, to see if the effect increases in line with implemented observations and quality improvement measures, or if the effect decreases during the study period.The intervention is to implement NOST, which includes:observation and recording of compliance with hand hygiene recommendations identification of areas for improvement training or other actions taken to improve IPC in general or compliance with hand hygiene. Thus, the intervention includes both observation of compliance and any additional improvement measures initiated as a result of the introduced NOST. When the intervention group has implemented and followed NOST for a year, investigators will measure compliance with hand hygiene recommendations and reported HAIs, in wards that have had NOST and in wards that have not introduced NOST. The intervention arm will be followed over time with repeated measurements of both compliance with hand hygiene and other outcome measures, to see if the effect increases in line with implemented observations and quality improvement measures, or if the effect decreases during the study period.
Masking:
Single (Outcomes Assessor)
Masking Description:
The reserachers who evaluates the outcome of interest will be masked for the group allocation.
Primary Purpose:
Prevention
Official Title:
Evaluation of the National Tool for Observation of Infection Prevention Measures in the Healthcare (NOST) - a Cluster Randomized Trial
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: NOST

The intervention is to implement NOST, which includes: observation and recording of compliance with hand hygiene recommendations identification of areas for improvement training or other actions taken to improve IPC in general or compliance with hand hygiene. Thus, the intervention includes both observation of compliance and any additional improvement measures initiated as a result of the introduced NOST. When the intervention group has implemented and followed NOST for a year, the investigators will measure compliance with hand hygiene recommendations and reported HAIs, in wards that have had NOST and in wards that have not introduced NOST. The intervention arm will be followed over time with repeated measurements of both compliance with hand hygiene and other outcome measures, to see if the effect increases in line with implemented observations and quality improvement measures, or if the effect decreases during the study period.

Behavioral: NOST
The intervention is to implement NOST, which includes: observation and recording of compliance with hand hygiene recommendations identification of areas for improvement training or other actions taken to improve IPC in general or compliance with hand hygiene. Thus, the intervention includes both observation of compliance and any additional improvement measures initiated as a result of the introduced NOST. When the intervention group has implemented and followed NOST for a year, the investigators will measure compliance with hand hygiene recommendations and reported HAIs, in wards that have had NOST and in wards that have not introduced NOST. The intervention arm will be followed over time with repeated measurements of both compliance with hand hygiene and other outcome measures, to see if the effect increases in line with implemented observations and quality improvement measures, or if the effect decreases during the study period.

No Intervention: Control

Participants in the no intervention arm arm are asked not to implement NOST.

Outcome Measures

Primary Outcome Measures

  1. Hand hygiene observations [Day 1 to one year later]

    Self-reported proportion of correct compliance, in total and by occupation

Secondary Outcome Measures

  1. Outbreaks of infectious diseases [Day 1 to one year later]

    Proportion of outbreaks per ward and secondary attack rate by inpatients and staff. Data collected from VESUV

  2. Surveillance of healthcare-associated infections [Day 1 to one year later]

    Proportion of infected inpatients by type of infections. Data collected from NOIS

  3. Surveillance of postoperative site infections [Day 1 to one year later]

    Proportion of infected patients by type of surgery and type of infections. Data collected from NOIS and POSI

  4. Length of stay [Day 1 to one year later]

    Mean and median bed-days per stay. Data collected from NRP

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Hospital wards with day- and night care.
Exclusion Criteria:
  • Intensivecare units.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Norwegian Institute of Public Health Oslo Norway 0213

Sponsors and Collaborators

  • Norwegian Institute of Public Health

Investigators

  • Principal Investigator: Petter Elstrøm, PhD, Norwegian Institute of Public Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Norwegian Institute of Public Health
ClinicalTrials.gov Identifier:
NCT05721183
Other Study ID Numbers:
  • NOST
First Posted:
Feb 9, 2023
Last Update Posted:
Feb 13, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 13, 2023